Saint Louis University looks for volunteers for avian flu vaccine study

[Shiloh]

Source: http://www.bizjournals.com/stlouis/stories/2008/09/08/daily19.html

SLU looks for volunteers for avian flu study

Saint Louis University School of Medicine seeks volunteers for one of the largest avian flu clinical trials in the nation to test a new vaccine approach to prevent the disease.

The study will test whether an injection of an FDA-approved avian flu vaccine created in 2004 can "prime" the body's immune system so a second shot of a different avian flu vaccine can protect against avian flu infection, the school said.

Avian flu occurs in birds and in rare instances has infected people. As of June, the World Health Organization reported 385 human cases of avian flu and 243 deaths in Asia, Europe and Africa. Public health experts are worried that avian flu could become the next influenza pandemic.

Saint Louis University is the lead site of the research, which is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. It will include up to five study sites. Of the 500 volunteers who are being recruited nationally, up to 167 people will be in St. Louis.

In November, Saint Louis University's Center for Vaccine Development received a seven-year, $23.7 million contract from the National Institutes of Health (NIH) to expand its research into promising vaccines and therapies for infectious diseases.

The Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River.

 

[gsgs]

Re: Saint Louis University looks for volunteers for avian flu vaccine study

> FDA-approved avian flu vaccine created in 2004

they mean, the virus is from 2004 ?
A/Vietnam/1203/2004(H5N1)

the only FDA-approved H5N1 vaccine is the high-dose Sanofi vaccine
without adjuvants, AFAIK. Seroconversion 45% or such

 

[Shiloh]

Re: Saint Louis University looks for volunteers for avian flu vaccine study

Source: http://www.healthnewsdigest.com/new...reparation_SLU_Launches_Avian_Flu_Study.shtml

Pandemic Preparation: SLU Launches Avian Flu Study
By Saint Louis University School of Medicine
Sep 8, 2008 - 7:31:15 PM

NIH-Funded Study Examines Combining Stockpiled and New Vaccines

(HealthNewsDigest.com) - ST. LOUIS Saint Louis University School of Medicine seeks volunteers for one of the largest avian flu clinical trials in the United States to test a new vaccine approach to prevent the disease.

The study will test whether an injection of an FDA-approved avian flu vaccine created in 2004 can "prime" the body's immune system so a second shot of a different avian flu vaccine can protect against avian flu infection. The second vaccine is an investigational vaccine, which has not yet been given to people.

"This study will answer several scientific questions, but the most important one is whether you can prime with one strain of influenza vaccine and boost the body's immune system with another," said Robert Belshe, M.D., director of the Center for Vaccine Development at Saint Louis University School of Medicine.

Vaccines protect against influenza by triggering the body to produce antibodies against infection. The study will examine the vigor of the body's antibody response and the safety of the vaccines.

Creating an effective vaccine for the avian flu is challenging. Like any other influenza bug, the avian flu virus ? known as H5 ? is constantly evolving. In addition, two doses of vaccine are likely to be needed to prevent avian flu infection, said Belshe, who is the study's principal investigator.

Avian flu occurs in birds, and in rare instances has crossed the species barrier to infect people. As of June 2008, the World Health Organization reported 385 human cases of avian flu and 243 deaths in Asia, Europe and Africa. The virus has not yet changed so it can be spread easily between people.

Public health experts are concerned that the avian flu could become the next influenza pandemic ? or outbreak of disease that sweeps around the globe, causing millions of deaths worldwide ? because previous outbreaks have been started by bird viruses. Consequently researchers are focused on finding a vaccine to protect against avian flu.

"Although many years have passed since the last major pandemic, the serious threat of pandemic influenza remains," Belshe said.

"So far there has been no substantial leap between the bird species and humans. However other pandemics have started when the organism jumps between species and we're worried it will happen again. A few genetic changes can occur in the virus and it would become highly infectious to humans. We're trying to prepare."

Saint Louis University is the lead site of the research, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and will include up to five study sites. Of the 500 volunteers who are being recruited nationally, up to 167 people will be enrolled at SLU's NIAID-funded Vaccine and Treatment Evaluation Unit (VTEU).

The study involves four to nine visits to the VTEU and overall the study lasts six to 12 months, depending upon the group to which a participant is randomly assigned.

Potential study volunteers must be healthy, between 18 and 49 years of age, not pregnant and not allergic to eggs.

Participants will receive two vaccines ? one or two doses of the 2004 avian flu vaccine that currently is stockpiled; one or two doses of the investigational vaccine that matches a different strain of the avian flu; or both vaccines.

For more information about enrolling in the study, please call the Saint Louis University VTEU at (314) 977-6333 or email vaccine@slu.edu.

 

[gsgs]

Re: Saint Louis University looks for volunteers for avian flu vaccine study

we had a post recently, that they consider to administer the expiring H5N1-vaccine instead of throwing it away
(should be at recombinomics)
and an article that Japan tests prepandemic H5N1 vaccine in >6000
medical personnal, they are considering to vaccinate 1M or even 10M,
there should be recent thread here

then there was a recent article showing, how vaccination with an
early H5N1 strain
(A/HK/213/? allowed successful boosting years later

I'm too lazy to search for the links

 

[Shiloh]

Re: Saint Louis University looks for volunteers for avian flu vaccine study

Source: http://www.thetelegraph.com/articles/vaccine_18655___article.html/pandemic_steen.html

Pandemic prep
'Pre-priming' the body with one flu vaccine could help in an outbreak, research suggests
September 29, 2008 - 1:14PM
By FORD VOX

If pandemic bird flu, smallpox or a rise in multidrug-resistant tuberculosis strikes the United States, Alton resident Melanie Steen will be better prepared than most.

Steen, 45, has become a frequent volunteer for vaccine trials at Saint Louis University's highly regarded vaccine development center. On Sept. 16, she received her fourth experimental vaccine. This time her well-tested immune system will add avian influenza to its hit list.

"It was pretty painless. The shot itself didn't hurt at all. I can feel where I was pricked but I can't see it," Steen said.

For that small inconvenience, Steen has the knowledge that she is helping SLU scientists determine the best way to protect Americans and the world from the possibility of pandemic bird flu.

"There's seasonal flu, which we all see every year. There's avian flu, which is a menace to birds and very rarely humans, when they get in the way. The third flavor would be pandemic flu," said Dr. Steve Lawrence, Associate Director of the Midwest Regional Center of Excellence (MRCE), one of 10 federal biodefense networks.

An unlucky emergency room doctor might recognize avian or pandemic flu by the severe hemorrhagic pneumonia it can cause. Some patients require a ventilator to breathe.

"There is a very exuberant immune response like there normally is to viruses, but this actually does a lot of tissue damage in the lungs, in addition to what the virus itself is doing," Lawrence said.

Lawrence is collaborating with other leading infectious disease scientists, health care providers and government officials to plan for the event of a first case of pandemic flu and the thousands that could follow.

Vaccination is integral part of the plan.

Scientists are targeting the H5N1 virus, a strain of avian flu so virulent it rapidly kills chicken eggs, which are currently the best culture medium for large-scale vaccine production. H5N1 (named for the specific proteins on its exterior) is widely regarded as the leading candidate for the next pandemic - a sudden and widespread disease outbreak.

"If it mutates to the point where it spreads efficiently from human to human, we would be on the verge of a new pandemic," said Dr. Robert Belshe, Director of the Center for Vaccine Development.

Recent research suggests "pre-priming" the body with one vaccine and then giving a booster of a different but similar vaccine in the middle of an outbreak may help.

SLU is the lead center among three funded by the National Institutes of Health to investigate the number of doses and amount of vaccine necessary for the body to mount the strongest immune response to H5N1.

In the trial, some volunteers will receive a well-studied vaccine based on a 2004 strain of H5N1 isolated in Vietnam, some will receive a new 2005 strain from Indonesia being tested in humans for the first time and some will receive both. Participants could receive one dose or a series.

While the only human cases of avian flu have been in faraway locales such as Southeast Asia, Eastern Europe and Africa, one man saw participating in the research as a patriotic duty.

"In the last 15 years, the U.S. has fallen short on many things," said volunteer Lance Leykam, 46, of Washington, Mo.

Proud that SLU research may be able to help the world through a potential crisis, Leykam said, "I think any healthy individual who has appreciation for their health and for others needs to participate to show their gratitude."

If a pandemic swept through the United States, essential services would break down without disaster continuity planning. Boeing, Southern Illinois University Edwardsville, Saint Louis University and Belleville Memorial Hospital have all hosted preparedness meetings produced by www.PandemicPrep.org, a local organization whose mission is to "prevent the social collapse that could occur as the result of a pandemic."

Despite these efforts, basic information is lacking.

"The Missouri hospital association has numbers on how many ICU beds we have, but actual numbers of ventilators and how many would be available, that data we are in the process of looking into," Lawrence said. "So even the number of people that could be taken care of at any given time under normal standards of care aren't completely known. The goal is that each of these facilities should try to be able to care for three times their normal number of critical care patients."

Alton Memorial Hospital has 12 intensive care unit beds.

With the health care infrastructure's stark capacity limits, many see vaccination as the best preparation.